Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125607711 | 12560771 | 1 | I | 20160120 | 20160701 | 20160715 | 20160715 | EXP | FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-055167 | BRISTOL MYERS SQUIBB | 48.68 | YR | F | Y | 0.00000 | 20160715 | CN | FR | FR |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125607711 | 12560771 | 1 | PS | COUMADINE | WARFARIN SODIUM | 1 | Oral | 2 MG, BID | Y | 9218 | 2 | MG | TABLET | BID | |||||
| 125607711 | 12560771 | 2 | SS | COUMADINE | WARFARIN SODIUM | 1 | Oral | 2 MG, BID | Y | 9218 | 2 | MG | TABLET | BID | |||||
| 125607711 | 12560771 | 3 | C | BISOCE | BISOPROLOL | 1 | Unknown | 5 MG, UNK | U | 0 | 5 | MG | |||||||
| 125607711 | 12560771 | 4 | C | DIFFU K | POTASSIUM CHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125607711 | 12560771 | 5 | C | LASILIX /00032601/ | FUROSEMIDE | 1 | Unknown | 80 MG, QD | U | 0 | 80 | MG | QD | ||||||
| 125607711 | 12560771 | 6 | C | LASILIX /00032601/ | FUROSEMIDE | 1 | Unknown | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 125607711 | 12560771 | 7 | C | SPECIAFOLDINE | FOLIC ACID | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125607711 | 12560771 | 1 | Heart valve replacement |
| 125607711 | 12560771 | 3 | Product used for unknown indication |
| 125607711 | 12560771 | 4 | Product used for unknown indication |
| 125607711 | 12560771 | 5 | Product used for unknown indication |
| 125607711 | 12560771 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125607711 | 12560771 | HO |
| 125607711 | 12560771 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125607711 | 12560771 | Cardio-respiratory arrest | |
| 125607711 | 12560771 | Cerebral haematoma | |
| 125607711 | 12560771 | Epilepsy | |
| 125607711 | 12560771 | International normalised ratio increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125607711 | 12560771 | 1 | 20160120 | 0 | ||
| 125607711 | 12560771 | 2 | 20160211 | 0 |